Critical Lower Limb IschemiaNCT04490408
Surgical Bypass Versus Hybrid Approaches for Critical Limb Ischemia
A study testing long surgical bypass and Hybrid approach in people with Critical Lower Limb Ischemia, run by Egyptian Biomedical Research Network.
Trial summary
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Critical Lower Limb Ischemia
- What is being tested?
- long surgical bypass and Hybrid approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2014to 17 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
- Fontaine classification stage IV (gangrene or necrosis).
- Rutherford grade III and IV category 5 and 6 with salvageable foot
Who cannot join
- heart failure
- liver failure
- renal impairment
About this study
Official title: Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
- Conditions
- Critical Lower Limb Ischemia
- Being tested
- long surgical bypass, Hybrid approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long surgical bypassProcedure or surgery
long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
Hybrid approachProcedure or surgery
Hybrid approach including bypass and endovascular revascularization
| Study group | Role | What they receive |
|---|---|---|
| long surgical bypass | Active comparator | long surgical bypass for multilevel lower limb ischemia Receives: Procedure: long surgical bypass |
| Hybrid approach | Experimental | surgical bypass and endovascular treatment for multilevel lower limb ischemia Receives: Procedure: Hybrid approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late occlusion
Late occlusion of the affected vessels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start20 Sep 2014
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Lower Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490408
- Sponsor's protocol ID
- EBRN71
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Surgical Bypass Versus Hybrid Approaches for Management of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04490408
- Acronym / sponsor ID
- EBRN71
- Conditions
- Critical Lower Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 20 Sep 2014 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long surgical bypass | Active comparator | Procedure: long surgical bypasslong surgical bypass for multilevel lower limb ischemia |
| Hybrid approach | Experimental | Procedure: Hybrid approachsurgical bypass and endovascular treatment for multilevel lower limb ischemia |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
- Fontaine classification stage IV (gangrene or necrosis).
- Rutherford grade III and IV category 5 and 6 with salvageable foot
Key exclusion criteria (3 listed)
- heart failure
- liver failure
- renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long surgical bypasslong surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia. | Procedure or surgery | long surgical bypass |
| Hybrid approachHybrid approach including bypass and endovascular revascularization | Procedure or surgery | Hybrid approach |
Primary outcome
Late occlusion
Time frame: 2 years
Late occlusion of the affected vessels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Critical Lower Limb Ischemia
Recruiting
FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW
Chronic Total Occlusion of Artery of the Extremities
RecruitingObservational study
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Peripheral Arterial Disease, Critical Limb Ischemia
Active, not recruitingObservational study
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Peripheral Arterial Disease, Critical Lower Limb Ischemia
Not yet recruitingPhase 1/2
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Peripheral Arterial Disease, Leg Ulcer
RecruitingObservational study
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia
Peripheral Arterial Disease, Critical Limb-Threatening Ischemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing long surgical bypass and Hybrid approach in people with Critical Lower Limb Ischemia, run by Egyptian Biomedical Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late occlusion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.